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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: agalsidase beta
Trade Name: Fabrazyme
Date Designated: 01/19/1988
Orphan Designation: Treatment of Fabry's disease.
Orphan Designation Status: Designated/Approved
Genzyme Corporation
One Kendall Square
Cambridge, Massachusetts 02139
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: agalsidase beta
Trade Name: Fabrazyme
Marketing Approval Date: 04/24/2003
Approved Labeled Indication: For use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types
Exclusivity End Date: 04/24/2010 
Exclusivity Protected Indication* :  
2 Generic Name: agalsidase beta
Trade Name: Fabrazyme
Marketing Approval Date: 03/11/2021
Approved Labeled Indication: treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease
Exclusivity End Date: 03/11/2028 
Exclusivity Protected Indication* :  treatment of pediatric patients 2 years of age up to patients 8 years of age with confirmed Fabry disease
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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